E-DRUG: WHO Alert 2/2016: Falsified yellow fever vaccine, SE Asia CRM:0003053
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From Rapid Alert <rapidalert@who.int> February 11, 2016
Please find attached an important alert concerning 'AMARIL' a falsified
yellow fever vaccine that is circulating in South East Asia. Please
forward this information to the National Regulatory Authorities, the
procurement centres/departments and any other relevant colleagues and
organizations.
WHO are calling for increased vigilance for this specific product and batch
number.
This alert will shortly be available on the WHO website:
http://www.who.int/medicines/publications/drugalerts/en/
If you have any question concerning this product or if you wish to report
incidents concerning falsified medical products please contact
rapidalert@who.int
With kind regards, the WHO SSFFC Global Surveillance Team
Rapid Alert Team *| Michael Deats | Pernette Bourdillon Esteve |
SSFFC Global Surveillance and Monitoring Project |
Essential Medicines and Health Products | World Health Organization HQ |
rapidalert@who.int
Details:
AMARIL stabilised yellow fever vaccine 2265
exp. June 2017
Pasteur Institute in Dakar
Ref. RHT/SAV/Alert 2.2016
11 February 2016
Medical Product Alert N° 2/2016
Falsified AMARIL yellow fever vaccines circulating in South East Asia
This Medical Product Alert relates to the confirmed circulation of
falsified versions of 'AMARIL stabilised vaccine' in South East Asia.
This vaccine is used to immunise against yellow fever and is a WHO
prequalified product. Yellow fever vaccine is on the WHO list of Essential
Medicines.
On the 9th of February 2016, the Pasteur Institute in Dakar, Senegal,
informed WHO that they had identified a falsified version of their 'AMARIL
stabilised vaccine' circulating in Bangladesh.
Genuine AMARIL vaccines and solvents are manufactured by the Pasteur
Institute in Dakar, Senegal
The Pasteur Institute in Dakar has confirmed there are a number of
falsified elements on the packaging, including a falsified expiry date, as
well as other inconsistencies that were identified through visual
inspection of photographs of the falsified products, as compared to the
genuine products. Laboratory analysis is pending.
Photographs of the falsified versions available in annex.
It is necessary to ensure that all vaccines and medical products are
obtained from authentic and reliable sources. Their authenticity and origin
should be carefully checked and verified with manufacturers before use.
No serious adverse reactions attributed to this falsified vaccine have been
reported at this stage. However, if you have been immunized with this
falsified product, or if you suffer an adverse event following an
immunisation with this falsified product, please seek immediate advice from
a qualified healthcare professional and report the incident to your local
Ministry of Public Health / National Medicines Regulatory Authorities/
National Pharmacovigilance Centre.
If you are in possession of the same products as above, please do not use,
contact a healthcare professional as soon as possible for advice and report
the incident as indicated above.
WHO requests increased vigilance for the supply chains of countries likely
to be affected by these falsified products. Vigilance should include
hospitals, clinics, pharmacies and any other vendors of medical products.
Authorities are asked to immediately notify WHO if this falsified product
is discovered. If you have any information on the supply and/or
distribution of the falsified product please contact rapidalert@who.int
E-DRUG@healthnet.org
Bruneton Carinne <carinne.bruneton@gmail.com>